Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans. LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. This can cause conditions known as high triglycerides in the blood and inflammation of the pancreas.

Investigational medications to treat LPLD are currently being developed. In order to see if these medications are effective, it is necessary to be able to accurately measure LPL activity in humans.

LPL activity has been successfully measured in animal models after giving heparin. Heparin is a blood thinner which is approved by the FDA. It is originally used to prevent blood clots. This study will administer heparin to healthy adults through intravenous infusion (IV). Blood samples will be collected before and after the infusion to test LDL levels.

The purpose of this study is to develop a cheap, more reliable standard for assessment of LPLD in patients

Study Overview

• Status: Completed
• Conditions: Lipoprotein Lipase Deficiency
• Intervention / Treatment: Drug: Heparin

• Study Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Male and female individuals

Description

Inclusion Criteria:

1. male and females between ages of 20-39

Exclusion Criteria:

1. Past history of LPL deficiency
2. Hypercholesterolemia (Cholesterol >200, LDL >160, HDL <35) hypertriglyceridemia (TG>150), any familial lipid disorder
3. Diabetes mellitus (type 1 or 2)
4. Uncontrolled hypertension SBP>140, DBP>90
5. History of hemorrhagic stroke
6. Current pregnancy
7. History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study
8. Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening
9. History of allergy to heparin
10. History of heparin-induced thrombocytopenia
11. Current smoking
12. Active ulcerative or angiodysplastic GI diseases
13. Thrombocytopenia or platelet disorders (Platelet count <100,000/UL)

14. Major health issues which may affect the safety of study subject, including but not limited to:

    • History of chronic kidney disease (eGFR<60)
    • Long term use of medications which alter lipid metabolism
    • History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)
    • History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia
    • Chronic use of ASA, anticoagulants, platelet inhibitors
    • Use of NSAIDS for more than 2 weeks prior to screening
    • Anemia (hemoglobin <13 g/dL)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Lipoprotein lipase levels	Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.	10-15 minutes post-heparin adminstration

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Robert Eckel, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hyperlipoproteinemia Type I; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 15-1412; UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No